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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02960243
Other study ID # H16-01694
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date December 2020

Study information

Verified date April 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily shake. The DBS surgical procedure involves implanting an electrode deep within the brain which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the vocal manifestation of ET and a number of individuals have both ET and EVT, and when these patients are implanted for their ET, their EVT symptoms are often also mitigated. This study aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition to this, we hope to determine which hemisphere of the brain is responsible for larynx control: left or right.


Description:

Essential Tremor (ET) is the most common movement disorder in adults, affecting approximately 5% of individuals over the age of 65. Of this 5%, roughly 20% of these patients suffer from Essential Voice Tremor (EVT): the phonatory manifestation of ET. Patients with EVT lose their ability to speak due to a tremor in the muscles of the larynx, pharynx, palate, and tongue. Because of this, an individual's quality of life is limited because they can no longer communicate effectively. The purpose of this study is to quantify to what degree Deep Brain Stimulation improves Essential Voice Tremor. In addition to this, we hope to examine which brain hemisphere is responsible for these positive results: right, left, or both, in a prospective, randomized, double-blinded manner. By finding out more about the subcortical control underpinning speech, we will be able to improve our treatments and understanding of EVT and other neurological speech disorders.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Participant has been implanted with the DBS for ET - Participant has significant voice tremor as determined by our laryngology/speech-language pathology team Exclusion Criteria: - Participant does not have history of aphasia or other speech/language deficits - Participant does not have history of stroke or multiple sclerosis

Study Design


Intervention

Device:
Deep Brain Stimulation
DBS System Medtronic DBS programming settings will be set to maximally alleviate limb tremor, primary reason for referral These settings will be used to evaluate effects of voice tremor as well

Locations

Country Name City State
Canada The Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Koller WC, Lyons KE, Wilkinson SB, Troster AI, Pahwa R. Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Mov Disord. 2001 May;16(3):464-8. — View Citation

Mandat T, Koziara H, Rola R, Bonicki W, Nauman P. Thalamic deep brain stimulation in the treatment of essential tremor. Neurol Neurochir Pol. 2011 Jan-Feb;45(1):37-41. — View Citation

Simonyan K, Ostuni J, Ludlow CL, Horwitz B. Functional but not structural networks of the human laryngeal motor cortex show left hemispheric lateralization during syllable but not breathing production. J Neurosci. 2009 Nov 25;29(47):14912-23. doi: 10.1523 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Patients will be asked to read a voice protocol designed to elicit voice tremor symptoms. This will be conducted at the end of every trial arm with a patient sitting in a rest position without moving upper or lower limbs. At the end of each trial period, typically 15 minutes after change in stimulation settings
Secondary Voice Tremor Severity At the end of the study, the kinetics of voice tremor and limb tremor will be analyzed to determine if there are any similarities or differences in the time course to deterioration Measured every 3 minutes for 15 minutes
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